Hamilton-G5

Ventilator, Continuous, Facility Use

Hamilton Medical AG

The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Hamilton-g5.

Pre-market Notification Details

Device IDK193228
510k NumberK193228
Device Name:Hamilton-G5
ClassificationVentilator, Continuous, Facility Use
Applicant Hamilton Medical AG Via Crush 8 Bonaduz,  CH 7402
ContactSimone Haller
CorrespondentSimone Haller
Hamilton Medical AG Via Crush 8 Bonaduz,  CH 7402
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-05-04

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